(150 days)
The Lunette Menstrual Cup (Models 1, 2) is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
The Lunette™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:
- Size 1 for light flow and women who have not had intercourse (diameter of 41 . mm, a height of 73 mm, and a volume of 25 ml)
- . Size 2 for heavy flow (diameter of 45 mm, a height of 78 mm, and a volume of 30 ml)
The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. The user's guide provides information about how to use and care for the Lunette™ menstrual cup (Attachment 5).
Lunette™ menstrual cup is a re-useable internal receptacle that is placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Lunette™ Menstrual Cup is positioned in the lower portion of the vagina. The cup does not touch the cervix or interfere with the menstrual flow through it.
This submission K091754 for the Lunette Menstrual Cup (Models 1, 2) is a 510(k) premarket notification. The device is found to be "substantially equivalent" to predicate devices, meaning it does not require new clinical studies to demonstrate safety and effectiveness.
Therefore, the submission does not contain acceptance criteria or study data demonstrating device performance in the way typically seen for novel devices requiring clinical validation.
Instead of a study proving the device meets acceptance criteria, the submission successfully argues that the Lunette Menstrual Cup is substantially equivalent to already cleared devices (Alicia™ Menstrual Cup (K070965) and Mooncup Menstrual Cup (K060852)). The basis for this determination is shared intended use, technological characteristics, and materials.
To address the specific points of your request for situations where a substantial equivalence determination is made, I will indicate why the information is not applicable or provided in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. For a 510(k) based on substantial equivalence, there are no specific performance acceptance criteria for a new clinical study. Instead, the device's characteristics are compared to those of already approved predicate devices. The submission indicates:
| Characteristic | Lunette Menstrual Cup (Models 1, 2) | Predicate Devices (Alicia™ K070965, Mooncup K060852) | Conclusion |
|---|---|---|---|
| Intended Use | Receptacle placed in the vagina to collect blood and cellular debris during menstruation | Receptacle placed in the vagina to collect blood and cellular debris during menstruation | Substantially Equivalent |
| Technological Characteristics | Collects menstrual fluid internally; Reusable silicone cup | Collects menstrual fluid internally; Reusable silicone cup | Substantially Equivalent |
| Materials | Silicone | Silicone | Substantially Equivalent |
| Dimensions | Size 1: 41mm dia, 73mm ht, 25ml vol; Size 2: 45mm dia, 78mm ht, 30ml vol | Similar dimensions to predicate devices | Substantially Equivalent |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set data from human subjects was required or provided in this 510(k) submission for substantial equivalence. The comparison is based on the characteristics of the device itself and its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set was required for this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was present in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical menstrual cup, not an AI or imaging device. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical menstrual cup, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was required to be established for the purpose of this substantial equivalence determination. The "ground truth" for a 510(k) of this nature is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. There is no AI component or algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, the establishment of its ground truth is also not applicable.
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K091754
8 of 10
November 9, 2009
Attachment D
Premarket Notification [510(k)] Summary [As required by section 870.92(c)]
Submitter:
Morris Waxler, Ph.D. FDA Regulatory Affairs Specialist Waxler Regulatory Consultancy LLC 1920 Arlington Place Madison, WI 53726-4002 608-219-7547 mwaxler@charter.net
Manufacturer Contact Information:
Mr. Heli Kurjanen Lune Group Ltd Koskitie 62 FI-35500 Korkeakoski Finland Tel. +358 50 355 4064 heli.kurjanen@lunette.fi
New device:
Trade or proprietary name: Lunette Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400
Predicates:
Alicia™ Menstrual Cup (K070965) Mooncup Menstrual Cup (K060852)
Description of the Device:
The Lunette™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:
- Size 1 for light flow and women who have not had intercourse (diameter of 41 . mm, a height of 73 mm, and a volume of 25 ml)
- . Size 2 for heavy flow (diameter of 45 mm, a height of 78 mm, and a volume of 30 ml)
NOV 1 3 2009
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November 9, 2009
The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. The user's guide provides information about how to use and care for the Lunette™ menstrual cup (Attachment 5).
Lunette™ menstrual cup is a re-useable internal receptacle that is placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Lunette™ Menstrual Cup is positioned in the lower portion of the vagina. The cup does not touch the cervix or interfere with the menstrual flow through it.
Intended Use/Indication for Use:
The Lunette™ Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Conclusions:
The Lunette™ Menstrual cup (Model 1 and Model 2) have the same intended use and technological characteristics as the cleared devices (K070965 and K060852). Moreover, any differences between the Lunette™ and the predicate devices do not : (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
Substantial Equivalence:
The Lunette™ Menstrual Cup is substantially equivalent to the Alicia Menstrual Cup (K070965) and the Mooncup Menstrual Cup (K060852) in materials, dimensions, intended use and indication for use. The Lunette™ is made of silicone similar to that used in the Alicia and the MoonCup.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that resembles a stylized eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Lune Group Ltd. % Morris Waxler, Ph.D. President Waxler Regulatory Consultancy LLC 1920 Arlington Place MADISON WI 53726-4002
NOV 1 8 2009
Re: K091754
Trade/Device Name: Lunette Menstrual Cup / Models 1, 2 Regulation Number: 21 CFR §884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: October 5, 2009 Received: October 8, 2009
Dear Dr. Waxler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10 November 9, 2009
Attachment E
Indications for Use
510(k) Number (if known): K091754
Device Name: Lunette Menstrual Cup / Models 1, 2
.
Indications For Use:
The Lunette Menstrual Cup (Models 1, 2) is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
AND/OR Over-The-Counter Use _ _ X ___ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __________
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_
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§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.